efficacy of vortioxetine versus escitalopram on cognitive function in patients with inadequate response to current antidepressant treatment of major depressive disorder

Conditions: Major Depressive Disorder

Summary: this study aims at evaluating the effect of vortioxetine on cognitive dysfunction in major depressive disorder (mdd) patients with inadequate response to current antidepressant treatment.


Eligibility criteria:
inclusion criteria: * the patient has mdd, diagnosed according to dsm-iv-tr™ recurrent mde (classification 296.3x) as confirmed using the mini international neuropsychiatric interview (mini). * the patient has depressive symptoms currently considered as non- or only partially responsive (inadequate response), to one adequate course of ssri/snri antidepressant monotherapy and is candidate for a switch in the investigator's opinion. * the patient wants to stop taking his/her current ssri/snri treatment due to inadequate response confirmed by the antidepressant treatment response questionnaire (atrq), \<50% response to current treatment). * the patient must have been treated by ssri/snri monotherapy (citalopram, paroxetine, sertraline, duloxetine, or venlafaxine) for at least 6 weeks at licensed doses prior to the screening visit. * the patient has a phq-9 total score ≥14. * the patient has a madrs total score ≥ 22. * the patient has had the current mde for ≤1 year. * the patient has a perceived deficits questionnaire - depression (pdq-d) total score \>25. * the patient is a man or woman aged ≥18 and ≤65 years. exclusion criteria: * the patient has a score ≥70 on the dsst (number of correct symbols) at the baseline visit. * the patient has physical, cognitive, or language impairment of such severity as to adversely affect the validity of the data derived from the neuropsychological tests. * the patient has any current psychiatric disorder or axis i disorder (according to dsmiv-tr™ criteria) other than mdd, as assessed using mini. * the patient has a current or has had a diagnosis of dysthymic disorder within 3 months preceding the onset of current episode (dsm-iv-tr™ criteria). * the patient has borderline, schizotypal, schizoid, paranoid, histrionic, antisocial personality disorders (axis ii) as comorbid or primary diagnosis (dsm-iv-tr™ criteria). * the patient has history of previous mdes considered as treatment resistant defined as inadequate response (incomplete or no therapeutic response) to two prior courses of at least 6 weeks of conventional antidepressant drugs in adequate dosages or, the patient has treatment-resistant depression in the investigator's judgement. * the patient suffers from personality disorders, mental retardation, pervasive development disorder, attention-deficit/hyperactivity disorder, organic mental disorders, or mental disorders due to a general medical condition (dsm-iv-tr™ criteria). * the patient has a diagnosis of alcohol or other substance abuse or dependence (excluding nicotine or caffeine) (dsm-iv-tr™ criteria) that has not been in sustained full remission at least 2 years prior to the screening visit. * the patient has a current diagnosis or history of manic or hypomanic episode, schizophrenia or any other psychotic disorder, including major depression with psychotic features (dsm-iv-tr™ criteria). other protocol defined inclusion and exclusion criteria may apply.

Keywords: vortioxetine cognition